CHLORDIAZEPOXIDE AND AMITRIPTYLINE HCL hydrochloride tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

CHLORDIAZEPOXIDE (UNII: 6RZ6XEZ3CR) (CHLORDIAZEPOXIDE - UNII:6RZ6XEZ3CR)

から入手可能:

Par Pharmaceutical Inc

INN（国際名）:

CHLORDIAZEPOXIDE

構図:

CHLORDIAZEPOXIDE 5 mg

処方タイプ:

PRESCRIPTION DRUG

認証ステータス:

Abbreviated New Drug Application

製品の特徴

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HCL- CHLORDIAZEPOXIDE AND
AMITRIPTYLINE
HYDROCHLORIDE TABLET
PAR PHARMACEUTICAL INC
----------
SUICIDALITY AND ANTIDEPRESSANT DRUGS
ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL
THINKING AND BEHAVIOR
(SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM
STUDIES OF MAJOR
DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE
CONSIDERING THE USE OF
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLETS OR ANY OTHER
ANTIDEPRESSANT IN A
CHILD, ADOLESCENT, OR YOUNG ADULT MUST BALANCE THIS RISK WITH THE
CLINICAL NEED. SHORT-TERM
STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF SUICIDALITY WITH
ANTIDEPRESSANTS COMPARED TO
PLACEBO IN ADULTS BEYOND AGE 24; THERE WAS A REDUCTION IN THE RISK
WITH ANTIDEPRESSANTS
COMPARED TO PLACEBO IN ADULTS AGED 65 AND OLDER. DEPRESSION AND
CERTAIN OTHER PSYCHIATRIC
DISORDERS ARE THEMSELVES ASSOCIATED WITH INCREASES IN THE RISK OF
SUICIDE. PATIENTS OF ALL
AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY SHOULD BE MONITORED
APPROPRIATELY AND
OBSERVED CLOSELY FOR CLINICAL WORSENING, SUICIDALITY, OR UNUSUAL
CHANGES IN BEHAVIOR.
FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE NEED FOR CLOSE
OBSERVATION AND
COMMUNICATION WITH THE PRESCRIBER. CHLORDIAZEPOXIDE AND AMITRIPTYLINE
HYDROCHLORIDE IS
NOT APPROVED FOR USE IN PEDIATRIC PATIENTS (SEE WARNINGS: CLINICAL
WORSENING AND SUICIDE
RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND PRECAUTIONS:
PEDIATRIC USE).
DESCRIPTION
Chlordiazepoxide and amitriptyline hydrochloride tablets combine for
oral administration,
chlordiazepoxide, an agent for the relief of anxiety and tension, and
amitriptyline, an antidepressant.
Each film coated tablet for oral administration contains 5 mg
chlordiazepoxide and 12.5 mg amitriptyline
(as the hydrochloride salt) or 10 mg chlordiazepoxide and 25 mg
amitriptyline as the hydrochloride
salt).
Each tablet contains the following inactive ingredients: colloidal
silicon dioxide, corn starch,
hypromellose, hydroxypropyl cellulose, isopropyl alc